Biceps tenodesis implants and delivery tools

ABSTRACT

Methods and devices are provided for anchoring a ligament or tendon to bone. In one embodiment, a surgical implant is provided having a sheath and an expander that is received within the sheath. Various delivery tools, including a sheath inserter and a driver, are also provided. In use, the sheath inserter can be used to position a tendon within a prepared bone hole, and it can be used to deliver the sheath with a guidewire coupled thereto into the bone hole. The driver can be provided for delivering the expander into the sheath. A loader can optionally be used to load the driver and expander onto the guidewire coupled to the implanted sheath.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a divisional of U.S. application Ser. No.14/610,618 filed on Jan. 30, 2015, entitled “Biceps Tenodesis Implantsand Delivery Tools,” which claims priority to U.S. Provisional Appl. No.62/067,701 filed on Oct. 23, 2014 and entitled “Biceps TenodesisImplants and Delivery Devices,” which are hereby incorporated byreference in their entireties.

FIELD

Surgical devices and methods are provided for anchoring tissue to bone,and more particularly surgical implants, delivery tools, and methods areprovided for securing a biceps tendon to the humerus.

BACKGROUND

Disorders of the long head of the biceps tendon are a common source ofshoulder pain and may occur in association with other diagnoses such asrotator cuff tears, superior labrum anterior posterior tears,impingement syndrome and capsular injuries, or may be present as anisolated source of shoulder pain. The treatment options for disorders ofthe long head of the biceps (LHB) continue to evolve and can include LHBtenodesis. In a tenodesis procedure, a suture is passed through the baseof the LHB to locate the LHB in the subacromial space and to provideproximal control during the dissection. Once the suture is placed, theLHB is cut near the glenoid attachment. A sizer can be used to measurethe tendon size and to thereby determine the appropriately sized bonescrew. Once the screw is selected, a bone hole is drilled and a tendonfork is then used to push the tendon down into the bone hole. A bonescrew is then delivered into the bone hole to anchor the tendon withinthe bone hole.

While current procedures can provide an effective means for anchoring atendon to bone, they can suffer from several drawbacks. For example,current procedures require the use of numerous tools, which can lead toa prolonged procedure and increased costs. The use of a screw can alsoincrease the risk of damage to the tendon, as rotation of the screw intothe bone hole can tear or sever through the tendon. Moreover, it can bedifficult to maintain the desired tension on the tendon while the screwis being implanted, as the tendon can become misaligned and or can slipduring insertion of the screw. Any tension applied to the tendon duringinsertion of the anchor can also cause the anchor to back-out of thebone hole.

Accordingly, there remains a need for improved methods and devices foranchoring tissue to bone, and in particular for performing a bicepstenodesis.

SUMMARY

Various implants, tools and methods are provided for attaching a tendonto bone. In one embodiment, an anchor assembly for anchoring a tendon tobone is provided and includes a sheath having a substantially soliddistal end with at least two sidewalls extending proximally therefromand separated by at least first and second slots. The sidewalls can havethreads formed on an internal surface thereof and the sidewalls candefine an inner lumen therebetween. The solid distal end of the sheathcan have a mating feature. The anchor assembly can further include aguidewire having a distal tip configured to releasably mate with themating feature in the sheath. In one embodiment, the mating feature canbe a threaded bore formed in the sheath and the distal tip on theguidewire can be threaded for threadably mating with the threaded bore.The guidewire can extend proximally from the sheath when mated thereto.The anchor assembly can further include an expander that can have agenerally elongate cylindrical configuration such that the expander isconfigured to be received within the inner lumen of the sheath. In oneembodiment, the expander can have threads formed on an external surfacethereof that can threadably mate with the threads formed on the internalsurface of the at least two sidewalls. The expander can further includea lumen extending therethrough to receive the guidewire.

In some embodiments, the sheath of anchor assembly can include at leastone anti-collapse tab formed on at least one of the sidewalls adjacentto one of the slots. The at least one tab can be configured to limitmovement of the sidewalls toward one another. In some embodiments, thesidewalls can have an increased thickness at a mid-portion thereof ascompared to proximal and distal portions thereof. In other embodiments,the sidewalls can include ribs extending radially therearound. Forexample, the ribs on a first sidewall of the anchor can be angleddistally and the ribs on a second opposite sidewall of the anchor can beangled proximally

The sheath can also include at least one anti-plunge tab extendingradially outward from a proximal-most end thereof. The anti-plunge tabcan be configured to limit an insertion depth of the sheath into a bonehole. The sheath can also at least one retaining tab extending radiallyoutward from the sheath at a predetermined distance from the anti-plungetab. The distance can be configured such that the anti-plunge tab can bepositioned on a proximal surface of cortical bone and the retaining tabcan be positioned on a distal surface of the cortical bone. In oneexemplary embodiment, the distance can be greater than about 0.5 mm.

In some embodiments, the anchor assembly can include a sheath that canhave a concave distal-facing end for seating a tendon. In someembodiments, the anchor assembly can include a sheath that can have aconvex proximal facing end.

In other aspects, the first and second slots can each have a proximalportion, a distal portion, and a transition region extending between theproximal and distal portions. The proximal and distal portions can eachhave a constant width, and the transition region can have a width thattapers inward in a distal direction. In an exemplary embodiment, alength of transition region can be substantially equally to a width ofthe proximal portion.

In another embodiment, a method for anchoring a tendon to bone isprovided. The method can include positioning a distal end of a sheathover a tendon extending across a bone hole. The sheath can have aguidewire mated thereto and extending proximally therefrom. The sheathwith the guidewire mated thereto can be advanced into the bone hole tocause the tendon to advance into the bone hole and extend between thesheath and the bone hole. A cannulated expander can be advanced alongthe guidewire and into the sheath to cause the sheath to expand outwardto anchor the tendon within the bone hole.

The method can include advancing the sheath into the bone hole using aninserter tool having the guide extending therethrough. The method canfurther include, after advancing the sheath, manipulating the insertertool to release the guidewire from a guidewire grasper in the insertertool, and removing the inserter tool from the guidewire. In anotherembodiment, when the expander is fully inserted into the sheath, theexpander and the sheath can be in full circumferential contact along amajority of a length thereof. In another embodiment, the expander can benon-rotatably advanced into the sheath, or alternatively a distalportion of the expander can be non-rotatably advanced into the sheath,and a proximal portion of the expander can be rotatably threaded intothe sheath.

In other aspects, the method can include advancing the expander alongthe guidewire using a driver tool. The driver tool can include an outershaft having opposed prongs on a distal end thereof that are positionedwithin opposed slots formed in the sheath. The driver tool can furtherinclude an inner shaft extending through the outer shaft and engagedwith the expander. The inner shaft can be rotated to advance theexpander into the sheath while the prongs on the outer shaft hold thesheath substantially stationary. The driver tool can be removed from theguidewire and the sheath leaving the sheath and the expander implantedin bone.

In another embodiment, an anchor assembly for anchoring a tendon to boneis provided and includes a sheath and a threaded expander. The sheathcan have a body with at least two sidewalls extending proximallytherefrom. The sidewalls can be separated by at least first and secondslots, and the sidewalls can define an inner lumen therebetween. Thesidewalls can further include threads formed on an internal surfacethereof. The threaded expander can be configured to be received betweenthe at least two sidewalls and to threadably mate with the threadsformed on the internal surface of the sidewalls. The sheath and thethreaded expander can be configured such that, when the expander isfully threaded into the sheath, a mid-portion of the sidewall expandsoutward by a distance that is greater than a distance that proximal anddistal portions of the sidewalls expand outward. The mid-portion thusdefines a maximum outer dimension of the sheath to anchor the sheathwithin a bone hole.

In some embodiments, the mid-portion of the at least two sidewalls canhave a thickness that is greater than a thickness of the proximal anddistal portions of the at least two sidewalls. In some embodiments, theexpander of the anchor assembly can have a minor diameter and thethreads on the expander define a major diameter. A minor diameter of theexpander can cause the sidewalls of the sheath to expand outward. Inother embodiments, a major diameter or both a minor and major diametercan cause the sidewalls of the sheath to expand outward. In someembodiments, the expander of the anchor assembly can include acylindrical proximal portion having a substantially constant diameter,and a tapering distal portion having a diameter that decreases distally.

In other aspects, a method for anchoring a tendon to bone is provided.The method can include positioning a distal end of a sheath over atendon extending across a bone hole. The sheath can be advanced into thebone hole to cause the tendon to be advanced into the bone hole. Anexpander can be inserted into an inner lumen of the sheath such that theexpander causes proximal, middle, and distal portions of the sheath toexpand outward. The mid-portion of the sheath can expand outward by adistance that is greater than a distance that the proximal and distalportions of the sheath expand outward. The mid-portion can thus define amaximum outer dimension of the sheath that prevents the sheath frombacking out of the bone hole.

In other aspects, the sheath can have threads formed on an inner surfacethereof. The expander can further include threads formed on an outersurface thereon. The expander can be inserted into the sheath byrotating the expander relative to the sheath to thread the expander intothe sheath. The expander can have a minor diameter and the threads onthe expander can define a major diameter. The minor diameter of theexpander can cause the sheath to expand outward. In other embodiments,the major diameter or both the minor and major diameters of the expandercan cause the sheath to expand outward.

In another embodiment, an anchor assembly for anchoring a tendon to boneis provided. The anchor assembly can include a sheath having asubstantially solid distal end, and at least two sidewalls extendingproximally from the distal end. The sidewalls can be separated by atleast first and second slots and the sidewalls can define an inner lumentherebetween. The sheath can further include at least one anti-plungetab extending from a proximal-most end of the sheath adjacent to theslots. The anti-plunge tab can be configured to prevent over-insertionof the sheath into a bone hole. The sheath can further include at leastone retaining tab extending from the sheath at a location distal to theanti-plunge tab. The retaining tab can be positioned a distance apartfrom the anti-plunge tab. The distance can be configured such that whenthe anti-plunge tab is on a proximal surface of a cortical bone, theretaining tab will extend beneath a distal surface of the cortical bone.The anchor assembly can further include a threaded expander that can bereceived between the at least two sidewalls on the sheath to cause thesheath to expand and engage the cortical bone.

In some embodiments, the at least one anti-plunge tab can include a pairof anti-plunge tabs, and the at least one retaining tab can include apair of retaining tabs. In some embodiments, the at least oneanti-plunge tab can extend radially outward by a distance that isgreater than a distance that the at least one retaining tab extendsradially outward. In some embodiment, the at least one anti-plunge tabcan be co-planar with the at least one retaining tab. In someembodiments the distance between the anti-plunge tab and the retainingtab can be greater than about 0.5 mm, and more preferably it can be inthe range of about 1.0 mm to 2.0 mm.

In other aspects, a method for anchoring a tendon to bone is provided.The method can include positioning a distal end of a sheath over atendon extending across a bone hole in a bone. The sheath can beadvanced into the bone hole such that the tendon is advanced into thebone hole. At least one anti-plunge tab extending from opposed sides ofa proximal-most end of the sheath can abut against a surface of the boneto limit an insertion depth of the sheath into the bone hole. At leastone retaining tab extending from sheath at a location distal to theanti-plunge tab can extend beneath a surface of the bone. An expandercan be inserted into the sheath to cause the sheath to expand outward.The retaining tab can expand to a diameter that is greater than adiameter of the bone hole to thereby prevent removal of the sheath fromthe bone hole, thereby anchoring the tendon within the bone hole.

In one embodiment, the anti-plunge tab can extend radially outward by adistance that is greater than a distance that the retaining tab extendsradially outward. The retaining tab can be inserted into the bone holewhile the anti-plunge tab can be prevented from being inserted into thebone hole. The bone can be, for example, cortical bone. The bone canhave a thickness of at least about 0.5 mm, and the anti-plunge tab canbe positioned at least about 0.5 mm apart from the retaining tab toreceive the bone therebetween.

In another embodiment, an anchor inserter tool is provided having afirst elongate body with first and second prongs extending distally froma distal end thereof and configured to extend along opposed slots formedin a sheath of an anchor assembly. The anchor assembly can also includea second elongate body slidably disposed relative to the first elongatebody. The anchor assembly can also include a handle assembly coupled toa proximal end of each of the first and second elongate bodies. Thehandle assembly can be configured such that the first elongate body hasfirst and second ranges of motion. The first elongate body in the firstrange of motion can be movable between a first position in which thefirst and second prongs extend distally beyond the second elongate bodyand a second position in which the first and second prongs are retainedwithin the second elongate body. The first elongate body in the secondrange of motion can be movable from the second position to a thirdposition in which the first elongate body is configured to cause aguidewire extending through the first elongate body and mated to thehandle assembly to be disengaged and released from the handle assembly.

In certain embodiments, the first elongate body can be an inner shaftand the second elongate body can be an outer shaft disposed around theinner shaft. In some embodiments, the second elongate body can include aclosed distal end having a central bore formed therein for receiving aguidewire. The second elongated body can further include first andsecond slots formed therein and extending radially outward from thecentral bore for receiving the prongs. In another embodiment, a distalportion of the second elongate body can include first and secondconcavities formed in opposite outer sidewalls thereof. In anotherembodiment, the first and second elongate bodies can be configured to bereleasably locked relative to one another such that movement of thefirst and second elongate bodies relative to one another is prevented.

In certain embodiments, the handle assembly can include a first biasingelement that applies a first biasing force that must be overcome to movethe first elongate body from the first position to the second position,and the handle assembly includes a second biasing element that applies asecond biasing force that must be overcome to move the first elongatebody from the second position to the third position. The second biasingforce can be greater than the first biasing force. The handle assemblycan also include a guidewire grasping element that can be configured toengage a proximal end of a guidewire coupled to a sheath of an anchorassembly and extending through the first elongate body. In otherembodiments, the handle assembly can include an actuator coupled to thefirst elongate body and configured to move the first elongate bodythrough the first and second ranges of motion. In other embodiments, thehandle assembly can include a first handle mated to the second elongatebody and having an engagement element formed therein for engaging aguidewire. The handle assembly can further include a second handle matedto the first elongate body for moving the first elongate body relativeto the second elongate body.

In another embodiment, a tendon anchoring system is provided. The systemcan include an anchor assembly having a sheath with at least twosidewalls at least partially separated by at least first and secondslots. The sidewalls can define an inner lumen therebetween. The anchorassembly can further include an expander that can be received within theinner lumen of the sheath. The system can also include an inserter toolthat can have an outer shaft with an inner lumen extending therethrough,and an inner shaft having first and second prongs formed on a distal endthereof. The prongs can be sized and dimensioned to extend along thefirst and second slots in the sheath and to extend distally beyond adistal end of the sheath. The inserter tool can also include a handleassembly coupled to a proximal end of the inner and outer shafts. Thehandle assembly can have an actuator configured to axially move theinner shaft relative to the outer shaft to thereby move the prongsbetween an extended position in which the prongs extend distally beyonda distal end of the outer shaft, and a retracted position in which theprongs are retracted into the distal end of the outer shaft.

In certain embodiments the outer shaft can have a closed distal endhaving a central bore formed therein for receiving a guidewire. Theouter shaft can also have first and second slots formed therein andextending radially outward from the central bore for receiving the firstand second prongs. In some embodiments, a guidewire can be mated to thesheath, and a guidewire grasping element in the handle assembly can beconfigured to engage a proximal end of the guidewire. In otherembodiments, the first and second prongs can include a connectorextending therebetween along a proximal portion of the prongs, and theconnector can have a central lumen extending therethrough. In yetanother embodiment, the sheath can include at least one anti-plunge tabextending radially outward from a proximal-most end thereof, and adistal facing surface of the outer shaft can include at least one recessformed therein for seating the at least one anti-plunge tab.

In other aspects, the actuator can move between a distal position on thehandle assembly in which the prongs extend distally beyond the distalend of the outer shaft, and a proximal position on the handle assemblyin which the prongs are retracted into the distal end of the outershaft. In certain embodiments, the actuator can be biased to the distalposition.

A method for anchoring a tendon to bone is also provided. The method caninclude attaching a sheath to an inserter tool such that a pair ofprongs on a distal end of an inner shaft of the inserter tool extendalong opposed slots formed in the sheath. The method can includemanipulating an actuator on a handle assembly of the inserter tool toretract the pair of prongs into an outer shaft of the inserter tool, andwith the prongs retracted, manipulating the handle assembly to advancethe sheath through tissue. After the sheath is advanced through tissue,the actuator can be manipulated to cause the prongs to extend along theopposed slots formed in the sheath and to extend distally beyond adistal end of the sheath. The method can further include positioning thetendon between the pair of prongs, and manipulating the handle assemblyto advance the prongs, with the tendon therebetween, and the sheath intoa bone hole. The inserter tool can be removed such that the anchor andthe tendon remain in the bone hole. In some embodiments, the method canfurther include inserting an expander into the sheath to cause thesheath to expand outward to anchor the tendon within the bone hole.

In certain embodiments, the method can include measuring a size of atendon to be anchored to bone by positioning the tendon between the pairof prongs on the distal end of the inner shaft of the inserter tool. Insome embodiments, measuring a size of a tendon can include measuring atendon using a first inserter tool having a pair of prongs spaced afirst distance apart, and measuring the tendon using a second insertertool having a pair of prongs spaced a second distance apart.

In other aspects, attaching the sheath to the inserter can includeadvancing a guidewire mated to the sheath proximally into a distal endof the inner shaft of the inserter tool to cause the guidewire to matewith a guidewire grasper in the handle assembly of the inserter tool. Insome embodiments, removing the inserter can further include manipulatingthe actuator to cause the guidewire grasper to release the guidewire.

In another aspect, an anchor driver tool is provided. The anchor drivertool can include an outer shaft having first and second prongs extendingdistally from a distal end thereof. The first and second prongs can beconfigured to extend into opposed slots formed in a sheath of an anchorassembly. The anchor driver tool can also include an inner shaftextending through the outer shaft and having a distal end configured tomate with an expander of an anchor assembly. A handle assembly can becoupled to a proximal end of the inner and outer shafts. The handleassembly can include an actuator configured to rotate the inner shaftrelative to the outer shaft to drive an expander coupled to a distal endof the inner shaft into a sheath coupled to the first and second prongsof the outer shaft. The outer shaft can be configured to hold the sheathin a substantially fixed position during rotation of the inner shaft. Insome embodiments, the actuator can include a knob on a proximal end ofthe inner shaft, and the handle assembly can include a stationary handleon a proximal end of the outer shaft.

In certain embodiments, the outer shaft can include opposed viewingwindows formed in a distal portion thereof, and/or opposed cut-outsformed in the distal end thereof for seating a tendon. In someembodiments, the outer shaft is freely rotatably movable relative to theinner shaft, and axial translation of the outer shaft relative to theinner shaft can be limited to a predetermined distance. In someembodiments, at least one of the inner and the outer shafts can includeat least one marking for indicating when an expander is fully seatedwithin a sheath.

In another aspect, a tendon anchoring system is provided and includes ananchor assembly and an inserter assembly. The anchor assembly caninclude a sheath having a generally elongate cylindrical configurationwith at least two sidewalls at least partially separated by at leastfirst and second slots. The sidewalls can define an inner lumentherebetween. The anchor assembly can also include an expanderconfigured to be received within the inner lumen of the sheath. Theinserter assembly can include an outer shaft having first and secondprongs formed on a distal end thereof. The prongs can be sized anddimensioned to be received within the first and second slots in thesheath. The inserter assembly can further include an inner shaftextending through the outer shaft and having a distal end configured tomate with the expander. A handle assembly can be coupled to a proximalend of the inner and outer shafts. The handle assembly can have anactuator configured to rotate the inner shaft to drive the expander intothe sheath while the outer shaft prongs hold the sheath in asubstantially fixed position

In certain embodiments, the tendon anchoring system can include a loaderhaving a pathway extending therethrough between proximal and distal endsthereof for seating the expander and a distal portion of the outershaft. The loader can include a funneled distal end.

In some embodiments, the prongs can have a length that is less than alength of the first and second slots such that the prongs extend onlypartially therein. In some embodiments, the actuator can include a knobon a proximal end of the inner shaft, and the handle assembly caninclude a stationary handle on a proximal end of the outer shaft. Insome embodiments markings can be formed on at least one of the inner andouter shafts for indicating when the expander is fully seated within thesheath.

In some embodiments, the outer shaft can include opposed viewing windowsformed in a distal portion thereof, and/or opposed cut-outs formed inthe distal end thereof for seating a tendon. In some embodiments, theouter shaft is freely rotatably movable relative to the inner shaft, andaxial translation of the outer shaft relative to the inner shaft islimited to a predetermined distance.

In another aspect, a method for anchoring a tendon to bone is provided.The method can include advancing a sheath and a tendon into a bone holein bone such that the tendon extends between the sheath and the bonehole. A pair of prongs on a distal end of an outer shaft of a drivertool can be inserted into opposed slots formed in the sheath implantedin the bone hole. The method can also include manipulating an actuatoron a handle assembly of the driver tool to rotate an inner shaftextending through the outer shaft to thereby advance an expander coupledto a distal end of the inner shaft into the sheath. The pair of prongson the outer shaft can hold the sheath substantially stationary whilethe inner shaft rotates the expander into the sheath. In someembodiments, the prongs can prevent the sidewalls of the sheath fromcollapsing radially inward.

In some embodiments, the inner shaft is freely rotatable relative to theouter shaft, and axial movement of the inner shaft to advance theexpander into the sheath can be limited to a predetermined distance. Inother embodiments, the inner shaft can be cannulated to receive aguidewire coupled to the sheath such that the guidewire axially alignsthe inner shaft and the outer shaft relative to the sheath.

In some embodiments, tabs on the sheath limit an insertion depth of thesheath into the bone hole. In some embodiments, the outer shaft caninclude opposed cut-outs formed in a distal end thereof. The tendon canextend into the opposed cut-outs when the prongs are inserted into theslots such that the outer shaft is positioned against a surface of thebone.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be more fully understood from the following detaileddescription taken in conjunction with the accompanying drawings, inwhich:

FIG. 1 is a perspective view of a biceps tenodesis system having asheath inserter, a sheath, a driver tool, and an expander screw;

FIG. 2 is a side perspective view of the sheath of FIG. 1;

FIG. 3 is another side perspective view of the sheath of FIG. 1;

FIG. 4 is a top view of the sheath of FIG. 1;

FIG. 5A is perspective view of the sheath of FIG. 1 shown with a guidewire for mating thereto;

FIG. 5B is a side perspective view of the sheath and the guide wire ofFIG. 5A shown mated;

FIG. 6 is a cross-sectional view of the sheath of FIG. 1;

FIG. 7 is another cross-sectional view of the sheath of FIG. 1;

FIG. 8A is a side perspective view of the expander screw of FIG. 1;

FIG. 8B is a side perspective view of another embodiment of an expanderthat is configured to be partially non-rotatably advanced into a bonehole and then rotatably advanced into the bone hole;

FIG. 8C is a side perspective view of another embodiment of an expanderthat is configured to be non-rotatably advanced into a bone hole;

FIG. 9 is a cross-sectional perspective view of the expander screw ofFIG. 1;

FIG. 10 is a perspective view of the inserter tool of FIG. 1;

FIG. 11A is an exploded perspective view of the inserter tool of FIG. 1;

FIG. 11B is a perspective view of one embodiment of a locking mechanismfor use with the inserter tool of FIG. 1;

FIG. 11C is a side view of the locking mechanism of FIG. 11B;

FIG. 12A is a partially transparent perspective view of a distal fork ofthe inserter tool of FIG. 1;

FIG. 12B is an end view of the distal fork of the inserter tool of FIG.1;

FIG. 12C illustrates another embodiment of an inserter tool having afork with deformable prongs, showing the tool about to be insertedthrough a bone hole in bone;

FIG. 12D illustrates the inserter tool of FIG. 12C inserted through thebone hole to cause the prongs on the fork to bow outward.

FIG. 13 is a perspective view of the distal fork and a portion of theouter shaft of the inserter tool of FIG. 1;

FIG. 14A is a perspective view of the guidewire of FIG. 5A extendingfrom the outer shaft of the inserter tool of FIG. 1;

FIG. 14B is a perspective view of a distal end of an outer shaft of aninserter tool according to another embodiment;

FIG. 14C is a side view of the outer shaft of FIG. 14B having a sheathcoupled thereto;

FIG. 15 is a side perspective view showing the sheath of FIG. 1 mountedonto the distal fork of the inserter tool of FIG. 1;

FIG. 16A is a side view of a size small inserter tool;

FIG. 16B is a side view of a size large inserter tool;

FIG. 17A is a side view of the inserter tool of FIG. 1, showing theinserter tool in an initial position;

FIG. 17B is a side view of the inserter tool of FIG. 17A, showing atrigger pulled proximally to retract a distal fork into a distal end ofan outer shaft of the tool;

FIG. 17C is a side view of the inserter tool of FIG. 17B, showing thetrigger pulled further proximally to release a guidewire from matingengagement with the inserter tool;

FIG. 18 is a side perspective view of the driver tool of FIG. 1;

FIG. 19 is a transparent exploded view of the tool driver of FIG. 18;

FIG. 20 is a transparent perspective view of a knob and a handle of thedriver tool of FIG. 18;

FIG. 21 is a perspective view of a distal end of an outer shaft of thedriver tool of FIG. 18;

FIG. 22 is side view of the distal end of the outer shaft of FIG. 21;

FIG. 23 is another side view of the distal end of the outer shaft ofFIG. 21;

FIG. 24A is a side view of the driver tool of FIG. 1, showing the drivertool in an initial position;

FIG. 24B is a side view of the driver tool of FIG. 24A, showing theouter shaft moved distally relative to the inner shaft;

FIG. 24C is a side view of the driver tool of FIG. 24B, showing theouter shaft moved further distally relative to the inner shaft;

FIG. 25 is a perspective view of one embodiment of a loader, shownhaving the expander screw and driver tool of FIG. 1 coupled thereto;

FIG. 26A is a side view of the loader of FIG. 25;

FIG. 26B is a front view of the loader of FIG. 26A, showing the expanderscrew of FIG. 1 about to be received therein;

FIG. 26C is a front view of the loader and expander screw of FIG. 26Bshown in the mated configuration, and being guided onto a guidewire;

FIG. 26D illustrates the loader, expander screw, and guidewire of FIG.26C, showing the loader removed leaving the expander screw positioned onthe guidewire;

FIG. 27A is a side view of one embodiment of a tendon measuring device;

FIG. 27B is a side view of a distal end of another embodiment of atendon measuring device;

FIG. 28 is a side view of another embodiment of a tendon measuringdevice;

FIG. 29 is a side view of another embodiment of a tendon measuringdevice;

FIG. 30 is another side view of the tendon measuring device of FIG. 29;

FIG. 31 is a side view of a distal end of the tendon measuring device ofFIG. 29;

FIG. 32 is a side view of a combination guidewire and bone hole drillingdevice according to another embodiment;

FIG. 33A is a side view of an embodiment of a combination tendonmeasuring and bone hole drilling device, showing a fork retracted withinthe distal end;

FIG. 33B is a side view of the device of FIG. 33A, showing the forkextended partially from the distal end;

FIG. 33C is a side view of the device of FIG. 33A, showing the forkextended fully from the distal end;

FIG. 34A is a side view of another embodiment of a tendon measuringdevice;

FIG. 34B is a side view of a distal portion of the tendon measuringdevice of FIG. 34A, shown positioned adjacent to a tendon to bemeasured;

FIG. 34C is a side view of the distal portion of the tendon measuringdevice and the tendon of FIG. 34B, showing the measuring devicemeasuring the tendon;

FIG. 35 is a top view of another embodiment of a bone hole preparationdevice;

FIG. 36 is a side view of the bone hole preparation device of FIG. 35;

FIG. 37 is an end view of a tip of the device of FIG. 35;

FIG. 38 is a side view of one embodiment of an angled tip of a bone holepreparation device;

FIG. 39 is a side view of one embodiment of a rounded edge tip of a bonehole preparation device;

FIG. 40A is a perspective view of a distal portion of the inserter toolof FIG. 1, shown measuring a tendon to be anchored to bone;

FIG. 40B is a perspective view of the distal portion of the insertertool of FIG. 40A with the sheath of FIG. 1 being loaded onto theinserter tool;

FIG. 40C is a perspective view of the inserter tool and sheath of FIG.40B, showing the assembly being used to dunk a tendon into a bone holein bone;

FIG. 40D is a perspective view of the sheath and inserter tool of FIG.40C, showing the sheath fully inserted into the bone hole;

FIG. 40E is a perspective view of the sheath of FIG. 40D, showing theinserter tool removed leaving the guidewire coupled to the implantedsheath;

FIG. 41A is a perspective view of the expander screw of FIG. 1 loadedonto the guidewire of FIG. 40E;

FIG. 41B is a perspective view of the expander screw of FIG. 41A,showing the driver tool of FIG. 1 being advanced over the guidewire;

FIG. 41C is a perspective view of the driver tool and expander screw ofFIG. 41B, with the driver tool engaged with the expander screw;

FIG. 41D is a perspective view of the driver tool and expander screw ofFIG. 41C, showing an outer shaft of the driver tool advanced distally toposition prongs on the outer shaft within slots in the sheath;

FIG. 41E is a perspective view of the driver tool and expander screw ofFIG. 41D, showing the expander screw fully driven into the sheath;

FIG. 41F is a perspective view of the driver tool and expander screw ofFIG. 41E, showing the driver tool removed, leaving the guidewireextending from the expander screw disposed within the sheath;

FIG. 41G is a perspective view of the sheath and expander screw of FIG.41F, showing the guidewire being removed from the implant;

FIG. 42A is a top view of another embodiment of a sheath havinganti-plunge tabs;

FIG. 42B is a side perspective view of the sheath of FIG. 42A;

FIG. 42C is a side perspective view of the sheath of FIG. 42A disposedin a bone hole and shown anchoring a tendon to the bone;

FIG. 42D is a top view of the sheath and tendon of FIG. 42C;

FIG. 43A is a top view of another embodiment of a sheath having aproximal flange;

FIG. 43B is a side perspective view of the sheath of FIG. 43A;

FIG. 43C is a side perspective view of the sheath of FIG. 43A disposedin a bone hole and shown anchoring a tendon to the bone; and

FIG. 43D is a top view of the sheath and tendon of FIG. 43C.

DETAILED DESCRIPTION

Certain exemplary embodiments will now be described to provide anoverall understanding of the principles of the structure, function,manufacture, and use of the devices and methods disclosed herein. One ormore examples of these embodiments are illustrated in the accompanyingdrawings. Those skilled in the art will understand that the devices andmethods specifically described herein and illustrated in theaccompanying drawings are non-limiting exemplary embodiments and thatthe scope of the present invention is defined solely by the claims. Thefeatures illustrated or described in connection with one exemplaryembodiment may be combined with the features of other embodiments. Suchmodifications and variations are intended to be included within thescope of the present invention.

Reference throughout the specification to “various embodiments,” “someembodiments,” “one embodiment,” or “an embodiment”, or the like, meansthat a particular feature, structure, or characteristic described inconnection with the embodiment is included in at least one embodiment.Thus, appearances of the phrases “in various embodiments,” “in someembodiments,” “in one embodiment,” or “in an embodiment”, or the like,in places throughout the specification are not necessarily all referringto the same embodiment. Furthermore, the particular features,structures, or characteristics may be combined in any suitable manner inone or more embodiments. Thus, the particular features, structures, orcharacteristics illustrated or described in connection with oneembodiment may be combined, in whole or in part, with the featuresstructures, or characteristics of one or more other embodiments withoutlimitation.

It will be appreciated that the terms “proximal” and “distal” may beused throughout the specification with reference to a clinicianmanipulating one end of an instrument used to treat a patient. The term“proximal” refers to the portion of the instrument closest to theclinician and the term “distal” refers to the portion located furthestfrom the clinician. It will be further appreciated that for concisenessand clarity, spatial terms such as “vertical,” “horizontal,” “up,” and“down” may be used herein with respect to the illustrated embodiments.However, surgical instruments may be used in many orientations andpositions, and these terms are not intended to be limiting and absolute.

In general, methods and devices are provided for anchoring a ligament ortendon to bone. In an exemplary embodiment, the methods and devices areused to perform a biceps tenodesis, however a person skilled in the artwill appreciate that the devices and methods can be used in variousprocedures and for anchoring any tissue to bone. In one embodiment, asurgical implant is provided having a sheath and an expander that isreceived within the sheath. Various delivery tools, including a sheathinserter and a driver, are also provided. In use, the sheath insertercan be used to position a tendon within a prepared bone hole, and it canbe used to deliver the sheath with a guidewire coupled thereto into thebone hole. The driver can be provided for delivering the expander intothe sheath. A loader can optionally be used to load the driver andexpander onto the guidewire coupled to the implanted sheath.

A person skilled in the art will appreciate that the surgical implants,delivery tools, and methods disclosed herein can be used with a varietyof surgical devices, including measuring devices, drills, and mallets,etc.

The embodiments described herein generally relate to systems and methodsfor preforming biceps tenodesis surgeries. In some embodiments, thesystem can include any one or more of the following components: ananchor assembly or an implant having a sheath and expander; a sheathinserter tool; a driver tool; and a loader. The components of the systemcan reduce the number of steps required to perform a biceps tenodesis,and can do so with minimal risk of injuring to the tendon.

FIG. 1 illustrates one embodiment of a biceps tenodesis system thatincludes a sheath inserter tool 300, a sheath 100 coupled to a distalend of the sheath inserter tool 300, a driver tool 400, and an expanderin the form of a screw 200 coupled to a distal end of the driver tool400. While not shown in FIG. 1, the system can also include a loaderconfigured to removably mate to the driver tool 400 and the screw 200,as well as various other devices, such as bone preparation tools andmeasurement devices.

The apparatus and methods described herein may have a number ofadvantages over existing techniques for preforming bicep tenodesis. Inparticular, the entire attachment preparation procedure can bestraightforward and requires a surgeon to take only a few quick steps toaffix the implant structure including the sheath and the expander to thebone. A risk of damaging the tendon during rotation of the expander orany other technique requiring rotation of a component in direct contactwith the tendon may be avoided. As a result, a risk of causing trauma tothe tendon can be reduced and the time required to prepare and affix thetendon can be significantly reduced, which can facilitate the surgeryand mitigate inconvenience to the patient. In addition, the describedtechniques can help save operating room costs.

Implant

FIG. 2 illustrates the implantable sheath of FIG. 1 in more detail. Ingeneral, the sheath is configured to seat a tendon therearound, and toreceive an expander therein which is effective to cause the sheathexpand into bone to anchor the tendon within a bone hole. The sheath canbe formed from any bio-compatible material, and it can optionally bebio-absorbable.

While the shape and configuration of the sheath can vary, in anexemplary embodiment the sheath 100 has a generally elongate cylindricalshape, with a circular or ovular cross-sectional geometry. The sheath100 has a proximal end 100 p and a distal end 100 d as shown in FIG. 2.As shown in the side view of the sheath 100 in FIG. 3, the sheath 100can be a split sheath, with a first sidewall 112 a and a second sidewall112 b that are connected at the distal end 100 d and that are separatedby first and second elongates slots 114 a, 114 b extending therebetween.The elongate slots 114 a, 114 b can extend from the proximal end 100 pand can terminate just proximal to the distal end 100 d. The slots 114a, 114 b are preferably shaped to seat a fork-member on the sheathinserter tool, as will be discussed in more detail below. In theillustrated embodiment, the slots 114 a, 114 b decrease in width in aproximal-to-distal direction. As further shown in FIG. 2, the distal end100 d of the sheath 100 can be solid and closed, however an innersurface 116 can include a bore 120 formed therein that is configured toreceive a guidewire 140 therein. The bore 120 is preferably a blind borethat is threaded for mating with a threaded tip of the guidewire 140,however the bore can optionally extending all the way through the distalend.

As shown above in FIG. 3, the elongate slots 114 a, 114 b formed in thesidewalls 112 a, 112 b of the sheath 100 can allow for sheath expansion.The slots 114 a, 114 b between sidewalls 112 a, 112 b of the sheath 100preferably have a width that is greater than a width of the forks(discussed below) so that the sidewalls 112 a, 112 b can collapse inwardtoward the fork to allow the tendon and the sheath 100 to be pushed intothe bone hole. For example, the slots 114 a, 114 b in the resting statecan have a width that is greater than a width of the fork to allow thesidewalls 112 a, 112 b of the sheath 100 to move radially inward towardthe fork by a first distance to a collapsed position. The sidewalls canalso be configured to flex and move radially outward away from theresting position by a second distance to an expanded position. In anexemplary embodiment, the sheath 100 is configured to have a restingstate in which the first and second distances are equal. Such aconfiguration can be advantageous as the sidewalls 112 a, 112 b movefrom a middle resting position, rather than having the resting positionbe in the expanded position and having the sheath flex through both thefirst and second distances. In use, prior to implantation the sidewalls112 a, 112 b can have a curvature that can be semi-circular. When thesheath 100 is inserted into the bone hole, the sidewalls 112 a, 112 bcan collapse into an oval orientation. When the sheath is expanded bythe expander, the sidewalls can expand to a circular orientation, whichcan help attain uniform compression all the way around the sheath 100.

In some embodiments, the sheath can be formed having a varied wallthickness. As shown in FIG. 6, an outer diameter Do of the sheath can besubstantially constant along the proximal portion and can taper distallyinward along the distal portion to facilitate insertion. The inner lumenof the sheath 100 can have both an inner minor diameter D1 and an innermajor diameter D2. The inner major diameter D2 (and optionally the innerminor diameter D1) of the sheath 100 can taper distally inward from theproximal end 100 p toward the distal end 100 d, such that a thickness ofthe sidewalls 112 a, 112 b at a mid-portion 100 m of the sheath 100 isgreater than a thickness at the proximal end 100 p and the distal end100 d of the sheath. As a result, when the screw 200 is inserted intothe sheath 100, a mid-portion 100 m of the sheath 100, i.e., a portionof the sheath which is placed under the cortex, can expand to a diameterthat is greater than a diameter of the sheath 100 at the proximal end100 p, i.e., a portion of the sheath positioned within the cortex. Theexpansion of the mid-portion 100 m thereby “anchors” the sheath 100 toprohibit retraction of the sheath 100 back through the bone holeopening.

As shown in FIG. 2, the sheath 100 can also include a distal facingsurface that is concave or saddled to seat the tendon thereon. Thissurface can be used to assist in the retention of the tendon during theinsertion or dunking of the tendon and sheath 100 into the bone hole.This feature can be used in conjunction with or independent of othertendon retention features.

As further shown, the sheath can include a convex proximal surface oneach side wall 112 a, 112 b. The convex shape provides a rounded edgethat can help avoid damage to any tissue in contact with the sheath.

The sheath 100 can also include various surface features formed thereonto facilitate engagement with the bone. In one embodiment, the sheath100 can have surface features, such as ribs 106 a, 106 b, 106 c, 106 d,106 e, and each rib can be uni-planar so as to allow the sheath to beinserted into bone without the need to rotate the sheath. A distalportion 102 of the sheath can be free of surface features. While ribsare shown, a person skilled in the art will appreciate that the sheathcan include various bone-engaging surface features, such as threads,teeth, or other protrusions.

As indicated above and further shown in FIG. 7, the interior of thesheath 100 can have a bore 120 formed in the solid distal tip of thesheath 100. The bore 120 can be configured to receive the guidewire 140.The sheath 100 can be pre-packaged on the guidewire 140 to enhance easeof use during the surgical procedure. In an exemplary embodiment, asshown in FIG. 11A, the guidewire 140 has a predetermined length that issufficient to allow the guidewire to mate to the sheath and to extendall the way through and into the handle portion of each of the inserterand the driver. The guidewire can also have a threaded distal tip 142that is configured to mate with threads (not shown) formed in the bore120 in the sheath 100. In one embodiment, the bore 120 is a blind boresuch that the guidewire 140 does not protrude through the distal end 100d and is retained inside the sheath 100. In an alternate embodiment, thebore can extend entirely through the distal tip thereby allowing theguidewire 140 to protrude through the end of the sheath 100.

As further shown in FIG. 7, the sheath 100 can include features formedon the internal surface of the sidewalls 112 a, 112 b. For example, thesidewalls 112 a, 112 b can include threads 124 formed on the innerfacing surfaces thereof for threadably mating with the screw 200. Insome embodiments, the threads can extend along a portion of the interiorof the sidewalls 112 a, 112 b or fully along the interior of thesidewalls 112 a, 112 b. Further internal features can include but arenot limited to ridges, engagement members, or detents that could be usedto assist the sheath 100 in pulling or engaging the screw 200 into itsfinal position. In an exemplary embodiment, the threads 124 are shapedto match threads on the screw 200 when the sheath 100 is in the expandedstate, not the resting state, as will be discussed in more detail below.

In some embodiments, the sheath 100 can include anti-plunge tabs formedat the proximal end 100 p. For example, FIGS. 2-7 illustrate fouranti-plunge tabs 110 a, 110 b, 110 c, 110 d that each have a generallyrectangular configuration and that extend radially outward from aproximal end 100 p of the sheath 100 to prevent over insertion of thesheath 100 into the bone hole. In particular, first and secondanti-plunge tabs 110 a, 110 b extend from opposed sides of the firstsidewall 112 a, and third and fourth anti-plunge tabs 110 c, 110 dextend from opposed sides of the second sidewall 112 b. The anti-plungetabs 110 a, 110 b, 110 c, 110 d are thus positioned adjacent to theslots 114 a, 114 b. The anti-plunge tabs 110 preferably extend radiallyoutward from the sheath 100 beyond a maximum outer dimension or diameterof the sheath so as to act as a stop that limits the insertion depth ofthe sheath into a bone hole.

FIGS. 42A-42D illustrate another embodiment of a sheath 150 havinganti-plunge tabs 156 a, 156 b, 156 c, 156 d formed at a top proximal end150 p. For example, FIG. 42A is a top view of a sheath having two pairsof anti-plunge tabs 156 a, 156 b, 156 c, 156 d that extend radiallyoutward from opposed sides of the sheath 150. In particular, as shown inFIG. 42B, first and second tabs 156 a, 156 c extend from opposed sidesof a first sidewall 158 a, and third and fourth tabs 156 b, 156 d extendfrom opposed sides of a second sidewall 158 b. The tabs 156 a, 156 b,156 c, 156 d are positioned adjacent to slots 154 a, 154 b that separatethe sidewalls 158 a, 158 b. The forked prongs of the inserter tool,discussed in further detail below, can mate with the slots 154 a, 154 bto insert the sheath 150 into the bone hole. In use, as shown in FIG.42C, the top surface 152 of the sheath 150 or the proximal end 150 p isconfigured to remain above the top surface of the bone 500. As shown inFIG. 42D, the anti-plunge tabs 156 a, 156 b, 156 c, 156 d will abut thetop surface of the bone, extending beyond the bone hole to limit theinsertion depth of the sheath 150 into the bone hole. The tabs 156 a-dare preferably oriented such that they are positioned on opposite sidesof the tendon, i.e., in a direction perpendicular to the tendon. Forexample, first and second tabs 156 a, 156 b can be position proximate tothe left side of the tendon 6001 and the third and fourth tabs 156 c,156 d can be positioned proximate to the right side of the tendon 600 r.The anti-plunge tabs 156 a, 156 b, 156 c, 156 d can compress the tendonagainst the bone to facilitate anchoring of the tendon to the bone.

FIGS. 43A-43D illustrate another embodiment of a sheath 160 having ananti-plunge feature. In this embodiment, the proximal end 160 p of thesheath 160 includes proximal flanges 162 a, 162 b extending radiallyoutward from the proximal surface 168 of each sidewall. In particular,the first and second proximal flanges 162 a, 162 b can extend fromopposite sides beyond the diameter 160D of the sheath 160. As shown inFIG. 43B, the sheath 160 can include opposed elongate slots 164 a, 164 bextending from the proximal end 160 p toward the distal end 160 d. Theelongate slots 164 a, 164 b can terminate just proximal to the soliddistal tip 166 and can be configured to couple to an inserter tool, aswill be discussed in further detail below. As shown in FIGS. 42A and42B, the first flange 162 a can extend between the first and secondelongate slots 164 a, 164 b, extending circumferentially around theperimeter of the proximal surface 168 of the first sidewall 170 a. Thesecond proximal flange 162 b can also extend between the first andsecond elongate slots 164 a, 164 b, extending circumferentially aroundthe perimeter of the proximal surface 168 of the second sidewall 170 b.The flanges 162 a, 162 b can each have a generally semi-circular oroblong shape. As shown by FIG. 43C, when the sheath is implanted in abone hole, the tendon 600 will be engaged between the proximal flanges162 a, 162 b and the surface of the bone. The proximal flanges 162 a,162 b can thus be positioned on the top surface of the tendon 600covering the bone. The proximal flanges 162 a, 162 b can be formed froma flexible material and can be configured to provide relief to thetendon by flexing. As shown in FIG. 43D, the outer edges 172 b, 147 b ofthe proximal flanges 162 a, 162 b can flex upward away from the surfaceof the bone while the inner edges 172 a, 174 a of the proximal flanges162 a, 162 b located proximate to the elongated slots 164 a, 164 b canflex downward toward the bone hole pressing the tendon 600 into place.In this embodiment, the flanges 162 a, 162 b are oriented in-line withthe tendon, such that the first flange 162 a extends across the tendonalong one side of the bone hole, i.e., the distal side, and the secondflange 162 b extends across the tendon along the opposite side of thebone hole, i.e., the proximal side.

Referring back to the embodiment of FIG. 2, the sheath 100 can furtherinclude cortical retaining tabs 108 a, 108 b positioned along themid-section of the sheath 100, e.g., at a location just distal to theproximal end 100 p. The cortical retaining tabs 108 a, 108 b arepreferably positioned about 2 mm from the proximal-most end such thatthe cortical retaining tabs 108 a, 108 b will be positioned just beyondcortical bone and within cancellous bone when the sheath 100 isimplanted in a bone hole. The cortical retaining tabs 108 a, 108 b canbe sized to match a diameter of the bone hole. This allows the corticalretaining tabs 108 a, 108 b to be passed into the bone hole. In otherwords, the cortical retaining tabs 108 a, 108 b can have an outerdiameter that is equal to or less than a maximum outer dimension ordiameter of the sheath 100. Once implanted and after insertion of thescrew into the sheath 100, the sheath will expand to cause the corticalretaining tabs 108 a, 108 b, or at least an outer corner thereof, toextend under a surface of the cortex to prevent pull out thereby lockingthe sheath 100 into the bone. In the illustrated embodiment, the sheath100 includes four cortical retaining tabs 108 a, 108 b, 108 c, 108 d,with two on opposite sides of each sidewall 112 a, 112 b. However, thesheath 100 can include any number of cortical retaining tabs 108 a, 108b

As shown in FIG. 4, the sheath 100 can also include anti-collapse tabs128 a, 128 b, 128 c, 128 d integrally formed or positioned on theinterior walls 126 a, 126 b for preventing collapse of the walls 126 a,126 b beyond a predetermined position. In the illustrated embodiment, anedge of each of the first and second sidewalls 112 a, 112 b, extendingadjacent to the first and the second elongate slots 114 a, 114 b, definefour anti-collapse tabs. The tabs can move toward one another, but theyact as a stop to prevent the sidewalls 112 a, 112 b from fullycollapsing. The tabs 128 a, 128 b, 128 c, 128 d can thus allow thesidewalls to collapse toward one another when the sheath 100 and tendonare inserted into bone but prior to completion of the procedure and theinsertion of the screw 200.

As indicated above, the sheath 100 is configured to receive a screw 200therein that is effective to expand the sheath 100 to anchor the sheath100 and ligament coupled thereto within a bone hole. As shown in FIG.8A, in one embodiment the screw 200 can have a generally cylindricalshape with a constant minor diameter D₁ along at least a proximalportion 200 p, and preferably along a majority of the length, e.g., morethan half of the total length. A distal portion 200 d of the screw 200can taper distally inward to a reduced diameter at the distal-most end.The screw 200 can have threads 202 formed there along and extendingalong the entire length to facilitate engagement with the sheath 100.The screw 200 can be fully cannulated for allowing the screw 200 to bedelivered over a guidewire 140, and the screw 200 can have a flatproximal facing surface 206 and a flat distal facing surface 208. Theproximal surface 206 and the distal surface 208, however, can havevarious shapes and the shape can be configured to conform to the sheathand/or the bone surface. As further shown in FIGS. 8A and 9, the innerlumen 210 can have a diameter that is sized to receive a guidewire. Atleast a proximal portion of the inner lumen 210 can be shaped to receivea driver tool. For example, as shown in FIG. 8A, the proximal portion200 p can have a hexagonal bore to receive a hexagonal drive tool.

Referring back to FIG. 1, the screw 200 can be inserted into the sheath100 during use. Upon insertion into the sheath 100, the screw 200 cancause the sheath 100 to expand. In an exemplary embodiment, the threads202 on the screw 200 have a height H_(t) (FIG. 8) that is less than aheight H_(g) (FIG. 6) of the internal threads 124 formed in the sheath100. This configuration will allow the minor diameter D₁ of the screw200 to contact the inner minor diameter D1 (FIG. 6) of the sheath 100and thereby cause expansion of the sheath 100. As a result, the threads202 are not sized to cause expansion of the sheath 100, and rather thanminor diameter of the screw 200 causes expansion. Additionally, thescrew 200 can be shaped to cause the thicker mid-portion of the sheath100 to expand radially outward by a distance that is greater than theproximal end 100 p and the distal end 100 d of the sheath, such that themid-portion 100 m forms the largest diameter of the sheath 100 in theexpanded state, as previously discussed with respect FIG. 7.

A person skilled in the art will appreciate that the expander can have avariety of other configurations, and the expander can be configured tobe non-rotatably inserted into the sheath, rotatably inserted into thesheath, or partially non-rotatably and partially rotatably inserted intothe sheath. FIG. 8B illustrates one embodiment of an expander 220 thatis configured to be partially non-rotatably inserted into the sheath andthen rotatably inserted into the sheath. In particular, the expander 220includes a proximal portion 220 p having threads 222 formed thereon, anda distal portion 220 d that is non-threaded and free of surfacefeatures. The length of the proximal and distal portions 220 p, 220 dcan vary, but in an exemplary embodiment each portion is about half ofthe entire length of the expander 220. The illustrated proximal portion220 p has a generally cylindrical shape with a constant minor diameterD₁, and the distal portion 220 d of the expander 220 tapers distallyinward to a reduced diameter at the distal-most end. The expander 220can be fully cannulated for allowing the expander 220 to be deliveredover a guidewire 140, and the expander 220 can have a flat proximalfacing surface 226 and a flat distal facing surface 228. In use, thenon-threaded distal portion 220 d of the expander 220 can benon-rotatably advanced into the sheath 100. Once the distal portion 220d is fully disposed within the sheath 100, the expander 220 can then berotated to thread the proximal portion 220 p into the sheath. The sheathcan include corresponding threads along an entire inner surface thereof,or along on a proximal portion of the inner surface thereof, for matingwith the threads 222 on the expander 220.

FIG. 8C illustrates another embodiment of an expander 240 that isconfigured to be non-rotatably advanced into a sheath. In general, theexpander 240 has a generally cylindrical shape with a constant minordiameter D₁ along a proximal portion 240 p and a convex belly along amid-portion 240 m to a distal portion 240 d. The distal portion 240 d ofthe expander 240 is tapered distally inward to a reduced diameter at thedistal-most end. The mid-portion 240 m and the distal portion 240 d canbe free of any surface features and can be relatively smooth. Theproximal portion 240 p, on the other hand, can include one or more ribsor flanges 242 formed thereon and extending circumferentiallytherearound. In the illustrated embodiment, the proximal portion 240 pincludes two ribs 242 formed thereon and spaced longitudinally apart.Each rib 242 includes a flat proximal-facing surface 242 p, and an outersidewall having a proximal constant diameter portion 242 c and a distaltapering portion 242 t. The ribs 242 have an outer diameter that isgreater than the minor outer diameter of the expander 240. The expander240 can be fully cannulated for allowing the expander 240 to bedelivered over a guidewire 140, and the expander 240 can have a flatproximal facing surface 246 and a flat distal facing surface 248. Inuse, the expander 240 can be non-rotatably advanced into the sheath 100.The ribs 242 on the proximal portion 240 can cause the sheath to expandoutward thereby anchoring the sheath within the bone hole.

Sheath Inserter

Various inserter tools are also provided for inserting the sheath 100and/or screw 200 into a bone hole. The inserter tool can also be used toperform various other functions in connection with insertion of thesheath into a bone hole. For example, the anchor inserter tool can beeffective to initially measure a size of a tendon. Multiple insertertools having different sizes can be provided, with the sizescorresponding to the appropriately sized sheath and screw to be usedtherewith. The inserter tool can also be configured to insert or“plunge” a tendon into a pre-drilled bone hole, and to maintain thetendon within the bone hole while delivering a sheath 100 into the bonehole. The inserter tool can further be configured to receive a guidewire140 therein that is coupled to the sheath 100. This can allow the sheath100 with the guidewire 140 mated thereto to be delivered into a bonehole, and the guidewire 140 can thereafter remain with the sheath 100and facilitate delivery of the an expander into the sheath. In certainexemplary embodiment, the inserter tool can be configured to fixedlyengage the guidewire 140 to prevent movement thereof during plunging ofthe tendon and during delivery of the sheath 100, and it can beconfigured to selectively release the guidewire 140 once the sheath 100is implanted to allow the tool to be removed from the guidewire 140,leaving the sheath 100 implanted with the guidewire 140 extendingtherefrom.

FIGS. 10-17 illustrate one exemplary embodiment of a sheath insertertool 300 and various components and features thereof. As shown, thesheath inserter tool 300 generally includes an outer component having ahandle 302 with an outer shaft 306 extending therefrom, and an innercomponent that includes a trigger 304 that is slidably coupled to thehandle 302 and an inner shaft 310 extending from the trigger 304 andthrough the outer shaft 306. The inner shaft 310 includes features forinteracting with the sheath. The sheath inserter tool 300 can alsoinclude features disposed within the handle 302 for controlling movementof the inner and outer shafts 310, 306 relative to one another, as willbe discussed in more detail below.

The handle 302 can have a variety of configurations, but in theillustrated embodiment the handle 302 on the outer component has agenerally elongate cylindrical configuration to facilitate graspingthereof. The handle 302 can have a bore extending therethrough from thedistal end 302 d and terminating just distal to the proximal-most end.In other embodiments, however, the bore can extend through the proximalend of the handle 302. The bore can be configured to receive variouscomponents for controlling movement of the inner and outer shaftsrelative to one another. A distal portion of the bore can receive theproximal end of the outer shaft 306 for mating the shaft to the handle.The handle 302 can further include elongate longitudinal cut-outs 338 a,338 b formed in opposite sidewalls thereof and in communication with theinner lumen. The cut-outs 338 a, 338 b can allow the trigger 304 on theinner component to extend therethrough and to slidably move there along.

The trigger 304 can also have various configurations, but as shown thetrigger 304 is generally T-shaped and includes distal facingfinger-gripping surfaces 340 a, 340 b. The trigger 304 extends laterallyoutward from opposed sides of the handle 302, through the cut-outs 338a, 338 b, and thus allows a user to place the proximal end 300 p of thehandle 302 in their palm and to grasp the trigger 304 with two fingersto pull the trigger 304 proximally. The trigger can thus slideproximally and distally relative to the handle. As further shown in FIG.11A, the trigger 304 can be fixedly mated to or integrally formed on theproximal end of the inner shaft 310. As a result, movement of thetrigger 304 relative to the handle 302 moves the inner shaft 310relative to the outer shaft 306.

As indicated above, the handle can include additional features forcontrolling movement of the inner and outer components relative to oneanother. As shown in FIG. 11A, the handle 302 includes a primary biasingmember 314 e.g., a spring, disposed therein and configured to apply adistal biasing force to the trigger 304. The primary biasing member 314thus pushes the trigger 304 and thus the inner shaft 310 distally. Inorder to move the trigger 304 and the inner shaft 310 proximallyrelative to the handle 302 and outer shaft 306, the biasing force mustbe overcome to cause compression of the primary biasing member 314. Inan exemplary embodiment, a first force can be applied to move thetrigger 304 in a proximal direction along a first range of motion, i.e.,a first distance, to cause at least partial compression of the primarybiasing member 314. The trigger 304 can also move further proximallyalong a second range of motion, i.e., a second distance, however thehandle 302 can be configured to prevent proximal movement beyond thefirst range of motion unless a second force is applied to the trigger,304 with the second force being greater than the first force. The secondbiasing member 318, e.g., a spring can provide the second force forproximal movement beyond the first range of motion. As shown in FIG.11A, the secondary biasing member 318 is located proximal to the primarybiasing member 314.

The handle can also include a feature for engaging the guidewire matedto the sheath. In one embodiment, a guidewire retainer or a guidewiregrasper 316 can be disposed between the primary and second biasingmembers 314, 318. The guidewire retainer 316 can include a bore 342formed therein that is configured to receive a proximal end of theguidewire 140 mated to the sheath 100. The bore 342 is preferably sizedto engage the guidewire 140 by compression fit to hold the guidewire 140in a fixed position. In one embodiment, the guidewire retainer 316 canbe formed from a compressible material to engage the guidewire. A personskilled in the art will appreciate, however, that other techniques canbe used to engage the guidewire. The guidewire grasper can move axiallywithin the handle and proximal movement to a certain position can causethe guidewire grasper to release the guidewire. The secondary biasingmember 318 can apply the distally-directed biasing force to theguidewire retainer 316 to prevent proximal movement of the guidewireretainer until the second force is applied to cause the retainer to moveproximally and release the guidewire.

In order to allow the secondary biasing member to apply a secondaryforce, the proximal end of secondary biasing member 318 can define anabutment surface. In particular, as shown, the handle 302 can include aproximal-most member, e.g., a handle plunge 320, that abuts theproximal-most inner surface of the handle 302, and that allows thesecondary biasing member 318 to be compressed between it and theguidewire retainer 316. In use, when the trigger 304 is moved proximallyby a first distance, through the first range of motion, the primarybiasing member 314 compresses. The secondary biasing member 318 appliesa biasing force to the guidewire retainer 316 that is sufficient toprevent proximal movement of the guidewire retainer 316, and thus toresist movement of the trigger 304 beyond the first range of motion.When desired, a greater force can be applied to move the trigger 304further proximally through the second range of motion. The greater forceneeds to be sufficient to overcome the biasing force of the secondarybiasing member 318. When the trigger 304 is moved further proximally,beyond the first range of motion and through the second range of motion,the guidewire retainer 316 will move proximally to cause the secondarybiasing member 318 to compress. As will be discussed in further detailbelow, proximal movement of the guidewire retainer 316 will release theguidewire 140, as the mating connection between the sheath 100 andguidewire 140, and abutment of the sheath 100 against the distal end ofthe outer shaft 306, will prevent the guidewire 140 from movingproximally with the guidewire retainer 316. The sheath inserter tool 300can thus be removed, leaving the guidewire 140 behind.

A person skilled in the art will appreciate that the handle can includeother features, such as a locking mechanism, for releasably locking theinner and outer components to one another. By way of non-limitingexample, FIGS. 11B and 11C illustrate one embodiment of a lockingmechanism that could be located on the handle 302 and configured toengage a proximal portion of the inner shaft 310. The locking mechanismincludes a lock 914 which can be disposed at various locations on thehandle 302. The lock 914 is generally in the form of an elongate shafthaving a cut-out formed therein. The cut-out includes a longitudinallyextending pin that is configured to be moved in and out of a hole in theproximal end of the inner shaft 310. When the lock 914 is pushed towardone side of the handle 302 and the pin extends through a hole, the innershaft is prevented from movement. Conversely, when the lock 914 ispushed toward the other side of the handle such that the pin is removedfrom the hole, the inner shaft is free to move. Accordingly, when in alocked position, the lock 914 prevents proximal movement of the actuatorand locks the inner and outer shafts from moving longitudinally withrespect to each other. When in the unlocked position, the actuator andthe inner shaft 310 can move proximally relative to the handle 302 andouter shaft 306. A person skilled in the art will appreciate that avariety of other locking mechanisms known in the art can be used to lockthe inner and outer components relative to one another.

As indicated above, the inner shaft 310 is coupled to and extends fromthe trigger 304 and can have a generally elongate cylindrical shape witha fork 308 on a distal end 300 d thereof. The fork 308 can function toboth measure a tendon, and to facilitate insertion of the tendon andsheath 100 into a bone hole. FIG. 12A is an enlarged transparent view ofthe fork 308, and FIG. 12B is an end view of the fork 308. As shown, thefork 308 includes first and second elongate prongs 324 a, 324 b thatextending longitudinally along opposed sides of a cylindrical centralportion 328. The elongate prongs 324 a, 324 b can each have a generallysquare or rectangular cross-sectional shape, and the prongs 324 a, 324 bcan be coupled to the cylindrical central portion 328 by connectors 326extending longitudinally along the entire length of the distal end. Theconnectors 326 can have a width We that is less than a width Wp of theprongs 324 a, 324 b. The central portion 328 can include a guidewirebore 330 or channel extending therethrough and sized to slidably receivethe guidewire 140 mated to the sheath 100. The pair of prongs 324 a, 324b can extending distally beyond the connectors 326 and the centralportion 328 by a predetermined distance D to thereby define a u-shapedrecess 322 between the pair of prongs 324 a, 324 b. The u-shaped recess322 can be configured to receive the sheath 100 therein, with the prongs324 a, 324 b extending into the opposed sidewall cut-outs in the sheath100. In one embodiment, the u-shaped recess 322 can include a conedshaped protrusion formed therein to provide support to the sheath 100.The protrusion can have a cylindrical proximal portion with a taperingdistal portion that decreases distally in diameter.

A person skilled in the art will appreciate that the first and secondelongate prongs on the fork can have a variety of other configurations.FIGS. 12C and 12D illustrate an embodiment of an inserter tool that issimilar to inserter tool 300 and includes an outer shaft 306′ and aninner shaft (not shown) with a fork 308′ on the distal end thereof. Inthis embodiment, the fork 308′ has prongs 324′ that are deformable andthat can be configured to bow or flex outward into a generally convexconfiguration. The inner shaft and the fork 308′ can configured to belocked relative to the outer shaft 306′, and in use such a configurationcan aid in dunking a sheath fully into a shallow bone hole, where thesheath length is less than the bone hole depth, but the overall lengthof the locked, extended retractable inserter forks are longer than thebone hole depth. In particular, FIG. 12C illustrates prongs 324′ havinga generally linear configuration. Once inserted through a bone hole Hand into bone B, the locked, extended, retractable inserter fork 308′can have a length that allows the prongs 324′ to abut against anopposite inner surface of the bone B. The prongs 324′ can thus deformand bow outward, as shown in FIG. 12D. The outward expansion of theprongs 324′ will occur below the near cortex, against the far interiorcortical wall, thus aiding in anchoring the sheath (not shown) fullyflush within the bone hole.

FIG. 13 illustrates the fork 308 extending from the distal end of theouter shaft 306. As shown, the outer shaft 306 has an outer diameterD_(b) that is greater than a maximum width Wp of the prongs 324 a, 324b. Such a configuration will allow the sheath proximal end to abut theouter shaft 306 distal end when the fork 308 is inserted into the sheath100.

As indicated above, the inner shaft can move axially relative to theouter shaft to retract and extend the fork into and from the outer shaft306. As shown in FIG. 14A, the barrel distal-facing end surface 306 dcan include a cut-out 336 formed therein that is shaped to match theshape of the fork 308 on the inner shaft 310. The cut-out 336 thusallows the fork 308 to be fully retracted into the outer shaft 306, asshown in FIG. 14A and also allows the guidewire 140 to be receivedtherein. When fully assembled, the guidewire 140 and the sheath 100mated thereto can be slid in a proximal direction into the distal end ofthe outer shaft 306. The guidewire 140 can be moved proximally until theproximal end of the guidewire 140 is received within and in engagementwith the guidewire retainer 316 in the handle 302. The sheath will abutthe distal end of the barrel to prevent further proximal movement of thesheath and the guidewire.

In another embodiment, shown in FIGS. 14B and 14C, the outer shaft 306″can include cut-outs or recesses 307″ that are configured to seat theanti-plunge tabs on the proximal end of the sheath 100. The recesses307″ can be formed on opposite sides of the cut-out 336″ for allowingthe anti-plunge tabs on the sheath to sit without the distal end of theouter shaft 306″. As further shown in FIGS. 14A and 14B, the outer shaft306″ can also optionally include features to facilitate percutaneousinsertion of the outer shaft 306″ through tissue. For example, aconcavity 308″ (only one is shown) can be formed in opposite sides ofthe outer shaft 306″ adjacent to the distal end to reduce the profile ofthe outer shaft and therefore facilitate insertion of the distal endthrough tissue. The concavity 308″ in each sidewall can also seat thetendon, providing relief for the tendon during advancement of the sheathinto the bone hole.

FIG. 15 illustrates the sheath 100 loaded onto the distal end of theinserter. As shown, the outer shaft 306 can have a diameter 306 d thatis greater than major diameter of the ribs on the sheath 100, and thatis greater than a maximum width between the prongs 324 a, 324 b on thefork of the inserter tool. The outer diameter of the outer shaft 306 canbe dimensioned with respect to the width of the anti-plunge tabs 110 a,110 b, 110 c, 110 d so that the distal end of the outer shaft 306 d canthus operate in conjunction with the anti-plunge tabs 110 a, 110 b, 110c, 110 d on the sheath 100 to prevent over insertion of the sheath 100into bone, as both the outer shaft 306 and the anti-plunge tabs 110 a,110 b, 110 c, 110 d can abut the bone surface when the sheath isinserted into an appropriately sized bone hole. The bone hole ispreferably reamed using a drill that is sized to correspond to theselected size of the sheath inserter tool 300. In particular, the bonehole can be reamed to have a diameter that is slightly greater than thediameter of the ribs 106 a, 106 b, 106 c, 106 d, 106 e on the sheath100, but less than the maximum width of the anti-plunge tabs 110 a, 110b, 110 c, 110 d on the sheath 100. The distal end of the outer shaft 306will also prevent proximal movement of the sheath 100 relative to theinserter tool, thereby maintaining the sheath and the guidewire attachedthereto in a fixed position, as will be discussed below.

In one embodiment, the sheath inserter can be provided in multiple sizesthat correspond to the size of the tendon and the anchor. FIGS. 16A and16B illustrate the sheath inserter of FIGS. 10 and 11A, with FIG. 16Ashowing a size small sheath inserter tool 300 s and FIG. 16B showing asize large sheath inserter tool 3001, as is evident from the increasedsize of the outer shaft 3061 and the fork 3081. FIGS. 17A-17C illustrateuse of the inserter. In FIG. 17A, the fork 308 is in the initial restingposition, extending from the outer shaft 306. In FIG. 17B, the fork 308is shown fully retracted into the outer shaft 306, with the trigger 304moved proximally through the first range of motion. FIG. 17C shows fullretraction of the fork 308 inside the outer shaft 306, and illustratethat further proximal movement through the second range of motion canrelease the guidewire 140. The sheath inserter tool 300 is preferablyinserted percutaneously through tissue with the fork 308 in the fullyretracted position.

Driver

Various driver devices are also provided for driving an expander intothe sheath once the sheath is implanted in a bone hole. FIGS. 18 and 19illustrate one exemplary embodiment of a driver tool 400. As shown, thedriver tool 400 generally includes a driver handle 402 having an innershaft 410 extending distally therefrom, and a knob 404 having an outershaft 406 extending distally therefrom. The inner shaft 410 extendsthrough the knob 404 and the outer shaft 406, with the driver handle 402positioned proximal of the knob 404. An anti-rotation fork 408 islocated on a distal end of the outer shaft 406 and can be configured toprevent rotation of the sheath 100 as the inner shaft 410 is used tothread the screw 200 into the sheath 100. The inner shaft 410 caninclude a guidewire channel 430 extending therethrough for allowing theguidewire 140 mated to the sheath 100 to be received therein.

The driver handle 402 and inner shaft 410 can have a variety ofconfigurations. In the illustrated embodiment, the driver handle 402 hasa generally elongate cylindrical configuration to facilitate graspingthereof. A bore 403 can extend through the handle and can include aproximal portion 403 a that is sized to receive the guidewire and anenlarged distal portion 403 b for receiving a proximal end of the innershaft 410. The inner shaft 410 is preferably fixedly mated to orintegrally formed with the driver handle 402. As shown in FIG. 19, theproximal end 410 p of the inner shaft 410 includes mating screws 418 a,418 b, 418 c for securely and fixedly mating the inner shaft 410 to thedriver handle 402. However other techniques, such as various mechanicalengagement mechanisms, welding, adhesives, etc., can be used.

The inner shaft 410 can have a general elongate cylindricalconfiguration with a distal end 410 d that is configured to mate to anexpander, such as screw 200. For example, the distal end 410 d caninclude a drive tip 432 formed thereon for engaging the screw 200. Inthe illustrated embodiment, the drive tip 432 has a hexagonalconfiguration for extending into a corresponding hexagonal drive socketformed in the screw to thereby allow the inner shaft 410 to rotate thescrew 200. In other embodiments, other alternative shapes thatnon-rotatably mate can be used. The inner shaft 410 can further includea guidewire channel 430 extending therethrough for allowing the screw200 and the inner shaft 410 to be slidably advanced over the guidewire140 mated to the sheath 100, as will be discussed further below.

The knob 404 and outer shaft 406 can also have a variety ofconfigurations, but as shown in FIGS. 18 and 19, the knob 404 isgenerally cylindrical with first and second opposed alignment indicatorsor tabs 414 a, 414 b. The tabs 414 a, 414 b can be aligned with prongs424 a, 424 b on the anti-rotation fork 408, discussed below, to indicatethe position of the prongs 424 a, 424 b to a user grasping the knob 404.The outer shaft 406 can have a generally elongate cylindricalconfiguration, with a proximal end 406 p that is received within aninner lumen that extends through the knob 404. The proximal end 406 p ofthe outer shaft 406 can be fixedly mated to the knob 404 using matingscrews 412 a, 412 b, or other mating techniques.

As indicated above, the outer shaft 406 and the knob 404 can be slidablydisposed over the inner shaft 410. In an exemplary embodiment, the outershaft 406 and the inner shaft 410 are freely rotatably relative to oneanother, however longitudinal movement of the inner shaft 410 and theouter shaft 406 relative to one another is limited. As shown in FIG. 19,the inner shaft 410 can include stop pins 416 a, 416 b disposed thereonand protruding radially outward from opposite sides thereof. The stoppins 416 a, 416 b can be located just distal of the proximal end of theinner shaft 410. When the knob 404 is disposed over the inner shaft 410,the stop pins 416 a, 416 b can be positioned within the inner lumen 434extending through the knob 404. The stops pins 416 a, 416 b and the knob404 can be configured such that the stop pins 416 a, 416 b only allowthe knob 404 to slide proximally and distally a predetermined distance.In particular, the knob 404 can include a reduced diameter region 428 dadjacent the distal end that limits distal movement of the pins 416 a,416 b, and a reduced diameter region 428 p adjacent the proximal endthat limits proximal movement of the pins. The proximal reduced diameterregion 428 p can, however, include opposed pin slots 420 a, 420 b formedtherein for allowing the pins 416 a, 416 b to pass therethrough whenproperly aligned with the slots 420 a, 420 b. Such a configurationallows the knob 404 and outer shaft 406 to be removed from the innershaft 410 and driver handle 402, e.g., for cleaning.

As indicated above, the distal end 406 d of the outer shaft 406 caninclude an anti-rotation fork 408 having first and second opposed distalprongs 424 a, 424 b extending distally from opposite sides of the outershaft 406. The prongs 424 a, 424 b can be configured to extend into thesidewalls slots in the sheath 100 to prevent rotation of the sheath 100when the inner shaft 410 is rotated to drive the screw 200 into thesheath 100. FIGS. 21-23 illustrate the prongs 424 a, 424 b in moredetail. As shown, each prong has a generally triangular configurationand extends from a semi-cylindrical sidewall. The prongs can thus extendinto the slots in the sheath 100, while the sidewall abuts against aproximal end surface of the sheath. Such a configuration will limitinsertion of the driver tool 400 into the sheath 100.

As further shown in FIGS. 21-23, the outer shaft 406 can also includefeatures to facilitate viewing of the screw 200 coupled to the drivertool 400 and disposed within the outer shaft 406. For example, the outershaft 406 can include one or more viewing windows or visibility windows426 formed therein at a location adjacent to the distal end. The viewingwindows 426 in the illustrated embodiment are in the form of elongateoval cut-outs formed through both sidewalls on opposite sides of theshaft and in alignment with the prongs 424 a, 424 b. However, theviewing windows can be at various locations and can have variousconfigurations to allow for visibility into the inner lumen. As furthershown, the outer shaft 406 can also include tendon cut-outs 422 a, 422 bpositioned on opposed sides of the outer shaft 406 and offset from theprongs 424 a, 424 b and visibility windows 426 by about 90 degrees. Thetendon cut-outs 422 a, 422 b can allow a tendon wrapped around thesheath 100 to protrude up into the cut-outs if needed.

In use, as shown in FIGS. 24A-24C, the screw can be mated to the drivetip 432 on the inner shaft 410. The anti-rotation fork 408 can beadvanced over the screw 200 such that the anti-rotation fork 408 canextend into the slots in the sheath 100 to prevent rotation of thesheath during insertion of the screw into the sheath. When the prongsare seated within the slots in the sheath, the driver handle 402 can berotated relative to the knob 404 to thereby rotate the inner shaft 410within the outer shaft 406. The inner shaft 410 will thus rotate anddrive the screw 200 into the sheath 100 while the outer shaft 406 holdsthe sheath 100 stationary and prevents it from rotating. Such aconfiguration is particularly advantageous as it prevents rotation ofthe tendon, since the tendon is positioned around the sheath. Moreover,the anti-rotation fork 408 can also be effective to prevent the sheath100 from backing-out of the bone tunnel during insertion of the screw200. Without the anti-rotation fork 408, the tendon can have a tendencyto pull the sheath out of the bone hole. The anti-rotation fork 408 canthus be used to push the sheath into the bone hole until the anti-plungetabs on the sheath rest against with the bone surface.

The driver can also include markings to facilitate use. For example, oneor more laser lines can be formed on the inner and/or outer shafts toindicate the position of the outer shaft relative to the inner shaft,thereby indicating the position of the screw relative to the sheath. Inthe illustrated embodiment, a first marking, in the form of a laseretched band 407, extends around the distal end portion of the outershaft 406 on the inserter tool, as shown in FIG. 21. A second marking,in the form of a laser etched band 411, extends around the distal endportion of the inner shaft 410, as shown in FIG. 19. Alignment of theband 411 on the inner shaft with the band 407 on the outer shaft willindicate that the expander screw is fully driven into the sheath. A pairof markings can also or alternatively be formed on the proximal portionof the device. As shown in FIG. 19, the inner shaft 410 can include apair of markings, in the form of laser etched bands 413, 415, that arelocated distal of the driver handle 402. The distal band 415 will alignwith the proximal end surface of the knob 404 when the device is in theinitial configuration, prior to driving the expander screw into thesheath. The distal band 413, when aligned with the proximal end surfaceof the knob 404, will indicate that the expander screw is fully driveninto the sheath.

Loader

The driver tool 400 can also optionally be used with a screw loadercartridge 500 to facilitate loading of the screw 200 onto the guidewirefor delivering the screw into the sheath. FIG. 25 illustrates oneembodiment of a screw loader cartridge 500. The screw loader cartridge500 can be formed from various materials, such as metal or a moldedplastic, and can have various shapes and configurations. In theillustrated embodiment, the screw loader cartridge 500 includes aproximal portion 500 p with wings 502 formed thereon to facilitategrasping, and a distal portion 500 d that is in the shape of a funnel504 that is cut almost in half. The screw loader cartridge 500 can thushave a generally planer side as shown. An elongate channel 506 can beformed in the proximal portion 500 p and it can extend toward the funnel504 and can communicate with the funnel 504. The channel 506 can beshaped to seat the screw 200 and optionally a distal portion of thedriver tool 400, including the anti-rotation fork 408. For example, thescrew loader cartridge 500 can seat the screw 200 and the anti-rotationfork 408 on the outer shaft such that the outer shaft is in itsproximal-most position and prevented from further movement. Such aconfiguration can help prevent rotation and axial translation of thedriver tool inner and outer shafts when the loader and expander aremated thereto. This can be particularly desirable for packaging andpreventing movement during shipping until use of the device. The screw200 can be held within the channel 506 by press fit or using othertechniques known in the art. When the screw 200 is seated within thechannel 506, the guidewire channel (not shown) extending through thescrew 200 can align with the opening of the funnel 504. In use, theguidewire can thus be inserted into the funnel 504, which will therebyguide the guidewire into the screw 200 for ease of insertion.

FIGS. 26A-26D illustrate use of the screw loader cartridge 500 forloading the screw onto the guidewire. FIG. 26A is a side view of thescrew loader cartridge 500, showing the screw 200 seated therein. Asshown in FIG. 26B, the screw 200 can simply be side-loaded into thechannel 506. As shown in FIG. 26C, the funnel 504 can receive and guidethe guidewire 140 into the screw 200. As shown in FIG. 26D, once thescrew 200 is advanced along the guidewire 140, the tabs 502 on the screwloader cartridge 500 can be grasped and used to pull back on the screwloader cartridge 500 and disengage the screw loader cartridge 500 fromthe screw 200. The loader can be discarded or optionally sterilized andreused. The components can optionally be shipped with the screw andloader pre-loaded onto the screw driver tool.

Tendon Sizer

As explained above, the fork on the inserter can be used to measure asize of a tendon to be anchored. In other embodiments, a separate toolcan additionally or alternatively be used to measure a tendon. FIGS.27A-31 include various embodiments for measuring the size of a tendon.In the embodiment of FIG. 27A, the tendon sizer 710 generally includes ahandle 711 with a shaft 712 extending distally therefrom. A distal endof the shaft 712 includes a sizer 713 having various cut-outs formedtherein, each with a different size. A tendon can be positioned withineach cut-out until the size of the tendon matches the size of thecut-out. Markings (not shown) can be provided on the tool to indicateeither the size of the tendon, or the size of the implant and tool setto use in connection with a tendon anchoring procedure. FIG. 27Billustrates a similar sizer 714, however the cut-out are aligned axiallyalong the distal end, rather than positioned in a circular orientationas in the FIG. 27A embodiment.

FIG. 28 illustrates another embodiment of a tendon measuring device 720that is similar to the device of FIG. 27A, but that includes aretractable wire loop 723 on a distal end thereof. A knob 724 on thehandle 721 can be slid proximally and distally to adjust a size of theloop 723. A tendon can thus be positioned within the loop, and onceadjusted to match the size of the tendon, the device can indicate thesize to the user.

FIGS. 29-31 illustrate another embodiment of a tendon measuring device730 that is similar to the device of FIG. 28, but rather than anadjustable wire loop, device 730 includes an adjustable arm 733 thatmoves with respect to a stationary arm 734 to allow a size of a tendonto be measured.

In other embodiments, a combination tendon measuring device and bonehole preparation device are provided. FIGS. 32-33C illustrate variousother devices for determining tendon size and/or for reaming a bonehole. In FIG. 32, a combination guidewire and bone reamer tool 760 isprovided. In general, the device has a shaft with a distal end in theform of a reamer for reaming a bone hole, and a guidewire extendsthrough the shaft. FIGS. 33A-33C illustrate a device that is similar tothe device of FIG. 32, but that is in the form of a combination reamerand sizer tool 770. In particular, the reamer includes a forked sizer772 slidably disposed therein. As the forked sizer 772 is extended fromthe distal end of the reamer, the fork expands in size for measuringtendons of differing size. The device can include markings or otherfeatures on a proximal end (not shown) for indicating the size of themeasured tendon and/or the size of the implant and tool set to be usedwith the tendon.

In another embodiment, as shown in FIG. 34A-34C, a tendon measuringdevice 780 is provided having a tamp 780 for measuring a tendon size.The device 780 includes a handle 781 having an elongate shaft 782extending distally therefrom with the tamp 780 formed on the distal endthereof. In use, the tamp 780 can be inserted and pressed down on thebicep tendon in the ream and dunk location, as shown in FIGS. 34B-C. Ifthe tendon compresses to a width of the tamp 780, the tendon requires asmall scheme tool and implant set. If the tendon compresses and it islarger than the tamp 780, as shown in FIG. 34C, then it requires a largescheme tool and implant set.

FIGS. 35-37 illustrate another embodiment of a device 810 that can beused to prepare a bone hole. The device 810 includes a generallyL-shaped handle 812 having first and second shafts 814, 816 extendingfrom opposed ends thereof. Each shaft can include a bone hole cutter 814a, 816 a formed on a distal end thereof. While the shape of the bonehole cutters 814 a, 816 a can vary, in an exemplary embodiment, as shownin FIG. 37, each cutter can have a generally triangular configurationwith truncated corners. One of the cutters, e.g., cutter 814 a can havea first size and the other cutter, e.g., 816 a can have a second sizethat differs from the first size. For example, the cutters can beprovided in small and large sizes that correspond to small and largeimplant and tool sizes. The user can thus select the shaft and cutterhaving an appropriate size. As indicated above, the cutters can have avariety of configurations. FIGS. 38-39 illustrate additional cutter tipconfigurations for forming a bone hole having a desired shape. In FIG.38, the cutter device 824 includes a tip having a protrusion 824 bextending from a side thereof for forming a notch in a proximal end of abone hole. The device can optionally include two protrusions for formingtwo notches. In FIG. 39, the cutter 826 b on the device 826 has aconfiguration that forms a rounded edge at the top of the bone hole.

Method

The various implants and devices disclosed herein can be used to performa variety of procedures in which it is desirable to anchor tissue tobone. FIGS. 40A-40E illustrate one exemplary method for performing abiceps tenodesis surgery. While the method is described in connectionwith the system of FIG. 1, a person skilled in the art will appreciatethat the method can be performed using various anchors and tools, andthat is can be performed for anchoring any tissue to any bone.

In a biceps tenodesis procedure, a biceps tendon is retrieved, e.g.,using suture, and a size of the tendon needs to be determined to allow asurgeon to select an appropriately sized implant and tools. This can beachieved using the sheath inserter tool 300. In particular, with thefork on the inner shaft fully retracted into the outer shaft, the sheathinserter tool 300 can be passed through tissue and positioned adjacentto the tendon and the implant site. As shown in FIG. 40A, the fork onthe sheath inserter tool 300 can be manipulated to position the tendon600 within the fork. If multiple inserter tools are provided, thesmallest tool is preferably used first and the tendon is positionedbetween the forks on the distal end. If the tendon fits, then theimplant (sheath and screw) that has a size corresponding to the size ofthe sheath inserter tool is used. If the tendon is too large and doesnot fit between the prongs on the fork, the next size inserter tool canbe used to again measure the tendon. In an exemplary embodiment, a kitis provided having a small and a large sheath inserter, a small and alarge implant (sheath and screw), and a small and large screw driver andloader. After properly sizing the tendon, the proper size reamer can beused to ream a bore in the bone, e.g., the humorous.

Various bone hole preparation devices can be used. During a bicepstenodesis procedure, improper preparation of the bone hole includingrough or uneven edges can cause damage to the tendon including tearingor trauma. In some embodiments, a dual or triple ended tool can be usedthat will break the edge of the bone opening with a quarter turn backand forth. For example, the tool of FIGS. 35-36 can be insertedpercutaneously, and the appropriately sized tip can be selected,inserted into the bone hole, and rotated by hand to form a bone holeopening as shown in FIG. 37. Alternatively, the device of FIG. 38 orFIG. 39 can be used to create an angled surface within the bone hole.The angled surface can provide an alternate means of bone holepreparation that can mitigate the potential for the tendon to rip ortear on a sharp edge of the bone.

After the bone hole is prepared, the tendon can be plunged into the bonehole using the appropriately sized inserter tool. The sheath andguidewire can be loaded onto the inserter tool prior to plunging thetendon. As shown in FIG. 40B, the guidewire 140 can be threaded into theinner bore in the sheath 100, which can be loaded into the distal end ofthe sheath inserter tool 300. This can be achieved by advancing theproximal end of the guidewire 140 into the distal end of the sheathinserter tool 300, and moving the guidewire 140 proximally until theguidewire 140 is press-fit into the guidewire retainer in the handle.The guidewire and sheath, or the guidewire, sheath, and inserter tool,can optionally be pre-packaged together in a mated configuration.

FIGS. 40C-40E illustrates various steps of inserting the sheath 100 andtendon 600 into the bone hole 602. For example, the fork 308 can beretracted by pulling proximally on the trigger through the first rangeof motion to allow for percutaneous insertion through the skin. The tipof the sheath can serve as an obturator to pass the sheath and insertertool through tissue. Once passed through tissue, the operator canrelease the trigger to allow the fork 308 to extend distally out of theouter shaft. The fork 308 can be position around the tendon 600. Asuture can be used to tension the tendon, and the forks can bepositioned proximal or distal to the hole with the tendon therebetween.The sheath will thus rest against the tendon. The fork 308, with thetendon therebetween, can then be slid toward the hole 602 and dunkedinto hole 602, as shown in FIG. 40C. The bone hole diameter can be sizedto allow the fork 308 and the sheath to be easily inserted thereon. Someresistance may be encounter due to the tendon being wrapped around thesheath. Since the outer shaft of the sheath inserter tool 300 isoversized compared to the tunnel 602, the outer shaft will be preventedfrom entering into the bone hole 602. If resistance is encountered, theproximal end of the inserter tool can be tapped with a mallet. Thecortical bone is typically only 1 mm to 2 mm thick. When tapping withmallet, the goal is to tap the cortical retaining tabs into the holeuntil the anti-plunge tabs on the sheath 100 abut the bone surface suchthat over insertion of the sheath into the hole is prevented. Thecortical retaining tabs are preferably sized so as to not cut throughthe bone when inserted therethrough. During the insertion process, thefork 308 can continue to straddle the tendon 600 all the way into bone602. When the sheath 100 is fully inserted, the anti-plunge tabs and thedistal end of the outer shaft will rest against the bone, as shown inFIG. 40D, and the cortical retaining tabs will extend below the corticalbone. The sheath inserter tool 300 can be removed by pulling the triggerthrough the first range of motion to retract the fork, and furtherproximally through second range of motion to thereby release theguidewire 140 from the handle. The sheath inserter tool 300 can then beslid off of the guidewire 140, leaving the sheath 100 in the bone hole602 with the guidewire 140 extending therefrom, as shown in FIG. 40E.

Once the sheath inserter tool 300 is removed, the screw 200 can bedriven into the sheath 100 using the driver tool 400. The screw 200 canbe loaded onto the driver tool 400 using the loader cartridge, or asindicated above the screw, loader, and driver can be pre-packaged in afully assembly configuration. As discussed above, the loader tab has afunneled distal tip to assist in positioning the guidewire into thescrew 200. The funnel can thus be advanced over the guidewire that isattached to the implanted sheath. The funnel will thereby guide theguidewire into the screw, which can be slid a distance down theguidewire. If desired, the screw driver can be advanced over theguidewire in conjunction with the screw. The loader can then be removed,and the driver tool 400 can be used to advance the screw 200 into thesheath 100, as shown in FIGS. 41A-41C. The prongs on the outer shaft ofthe driver tool 400 will extend into the slots in the sheath 100, asshown in FIG. 41D. The driver tool 400 can hold the sheath 100 withinthe bone hole 602, preventing back out during screw 200 insertion. Theviewing windows opposite one another and aligned with the tines canfacilitate viewing of the screw, and the side cut-outs offset from theviewing windows can receive the tendon so as to allow outer shaft torest against sheath, as shown in FIG. 41D. In some embodiments, theouter shaft could be formed from a transparent material to allow viewingtherethrough.

Once the driver tool 400 is seated with the outer shaft resting againstbone, the outer shaft handle is held stationary while the inner shaftknob is rotated to drive the screw 200 into the sheath 100, as shown inFIG. 41E. In one embodiment, as discussed above, the shaft can have twolaser lines, one on the inner shaft the other one on the outer shaft.When they are aligned, the screw 200 will be fully inserted. Theproximal end of inner shaft can also have a line that will align withthe knob on the outer shaft to indicate full insertion of the screw 200into the sheath 100. The line can be particularly useful when theprocedure is done without a scope (e.g., sub-pec during mini-openprocedure). When the screw 200 is fully inserted into the sheath 100,the screw will cause the sheath to expand radially outward to engage thetendon between the sheath and the bone hole, and to thereby anchor thesheath and tendon within the bone hole. The ribs on the outer surface ofthe sheath can engage bone to prevent back-out. The expanded mid-portionof the sheath, as well as the cortical retainer tabs, can also helpretain the sheath within the bone hole. As shown in FIGS. 41F-41G, oncethe screw 200 is fully inserted into the bone hole, the driver tool 400can be slid off of the guidewire 140. The guidewire 140 can be removed,e.g., by bending the proximal end and turning the guidewire 140, tounthread it from the sheath 100.

A person skilled in the art will appreciate that the biceps tenodesismethods and devices disclosed herein can be used in a variety ofsurgical procedures to trauma or damage to a tendon being attached to abone via a bone hole. The present invention also has application inconventional joint repair surgeries.

The devices disclosed herein can be designed to be disposed of after asingle use, or they can be designed to be used multiple times. In eithercase, however, the device can be reconditioned for reuse after at leastone use. Reconditioning can include any combination of the steps ofdisassembly of the device, followed by cleaning or replacement ofparticular pieces, and subsequent reassembly. In particular, the devicecan be disassembled, and any number of the particular pieces or parts ofthe device can be selectively replaced or removed in any combination.Upon cleaning and/or replacement of particular parts, the device can bereassembled for subsequent use either at a reconditioning facility, orby a surgical team immediately prior to a surgical procedure. Thoseskilled in the art will appreciate that reconditioning of a device canutilize a variety of techniques for disassembly, cleaning/replacement,and reassembly. Use of such techniques, and the resulting reconditioneddevice, are all within the scope of the present application.

Preferably, the invention described herein will be processed beforesurgery. First, a new or used instrument is obtained and if necessarycleaned. The instrument can then be sterilized. In one sterilizationtechnique, the instrument is placed in a closed and sealed container,such as a plastic or TYVEK bag. The container and instrument are thenplaced in a field of radiation that can penetrate the container, such asgamma radiation, x-rays, or high-energy electrons. The radiation killsbacteria on the instrument and in the container. The sterilizedinstrument can then be stored in the sterile container. The sealedcontainer keeps the instrument sterile until it is opened in the medicalfacility.

It is preferred that device is sterilized. This can be done by anynumber of ways known to those skilled in the art including beta or gammaradiation, ethylene oxide, steam.

One skilled in the art will appreciate further features and advantagesof the invention based on the above-described embodiments. Accordingly,the invention is not to be limited by what has been particularly shownand described, except as indicated by the appended claims. Allpublications and references cited herein are expressly incorporatedherein by reference in their entirety.

What is claimed is:
 1. A tendon anchoring system, comprising: an anchor assembly having: a sheath having a generally elongate cylindrical configuration with at least two sidewalls at least partially separated by at least first and second slots, the sidewalls defining an inner lumen therebetween, and an expander configured to be received within the inner lumen of the sheath; and an inserter assembly having: an outer shaft having first and second prongs formed on a distal end thereof, the first and second prongs being sized and dimensioned to be received within the first and second slots in the sheath, an inner shaft extending through the outer shaft and having a distal end configured to mate with the expander, and a handle assembly coupled to a proximal end of each of the inner and outer shafts, the handle assembly having an actuator configured to rotate the inner shaft to drive the expander into the sheath while the first and second prongs of the outer shaft hold the sheath in a substantially fixed position.
 2. The tendon anchoring system of claim 1, wherein the actuator comprises a knob on a proximal end of the inner shaft, and the handle assembly includes a stationary handle on a proximal end of the outer shaft.
 3. The tendon anchoring system of claim 1, wherein the outer shaft includes opposed viewing windows formed in a distal portion thereof.
 4. The tendon anchoring system of claim 1, wherein the outer shaft includes opposed cut-outs formed in the distal end thereof for seating a tendon.
 5. The tendon anchoring system of claim 1, wherein the outer shaft is freely rotatably movable relative to the inner shaft, and axial translation of the outer shaft relative to the inner shaft is limited to a predetermined distance.
 6. The tendon anchoring system of claim 1, further comprising markings formed on at least one of the inner and outer shafts for indicating when the expander is fully seated within the sheath.
 7. The tendon anchoring system of claim 1, wherein the first and second prongs have a length that is less than a length of the first and second slots such that the first and second prongs extend only partially therein.
 8. The tendon anchoring system of claim 1, further comprising a loader having a pathway extending therethrough between proximal and distal ends thereof for seating the expander and a distal portion of the outer shaft, the loader including a funneled distal end.
 9. A method for anchoring a tendon to bone, comprising: advancing a sheath and a tendon into a bone hole in bone such that the tendon extends between the sheath and the bone hole; inserting a pair of prongs on a distal end of an outer shaft of a driver tool into opposed slots formed in the sheath implanted in the bone hole; manipulating an actuator on a handle assembly of the driver tool to rotate an inner shaft extending through the outer shaft and thereby advance an expander coupled to a distal end of the inner shaft into the sheath, the pair of prongs on the outer shaft holding the sheath substantially stationary while the inner shaft rotates the expander into the sheath.
 10. The method of claim 9, wherein the pair of prongs prevent sidewalls of the sheath from collapsing radially inward.
 11. The method of claim 9, wherein the inner shaft is freely rotatable relative to the outer shaft, and axial movement of the inner shaft to advance the expander into the sheath is limited to a predetermined distance.
 12. The method of claim 9, wherein tabs on the sheath limit an insertion depth of the sheath into the bone hole.
 13. The method of claim 9, wherein the outer shaft further includes opposed cut-outs formed in a distal end thereof, and wherein the tendon extends into the opposed cut-outs of the outer shaft when the pair of prongs of the outer shaft are inserted into the opposed slots formed in the sheath such that the outer shaft is positioned against a surface of the bone.
 14. The method of claim 9, wherein the inner shaft is cannulated to receive a guidewire coupled to the sheath such that the guidewire axially aligns the inner shaft and the outer shaft relative to the sheath. 